Field of the Invention
The present invention in general relates to probiotic formulations and their therapeutic effects. In specific, the present invention discloses a process for the therapeutic management of diarrhea predominant irritable bowel syndrome in humans comprising the oral administration of Bacillus Coagulans SBC37-01, MTCC 5856 (containing not less than 2 billion spores) along with standard treatment of care in a specific manner.
Description of Prior Art
The World Health Organization's 2001 definition of probiotics is “live microorganisms which, when administered in adequate amounts, confer a health benefit on the host” and are able to prevent or improve some diseases (Eric P (2007) Probiotics and prebiotics renaissance of a therapeutic principle. Cent Eur J Med 2: 237-270). Consumption of probiotics is associated with a range of health benefits including stimulation of the immune system, protection against diarrheal diseases and nosocomial and respiratory tract infections, lowering of cholesterol, attenuation of overt immunoinflammatory disorders and anticancer effects (Britton R, Versalovic J (2008) Probiotics and Gastrointestinal Infections. Interdisciplinary Perspectives on Infect Dis 2008: 1-10, and Gill H, Prasad J (2008) Bioactive Components of milk: Probiotics, immunomodulation, and health benefits, in Advances in Experimental Medicine and Biology, ed by Bösze Z. Springer, New York USA, pp 423-454). Most probiotic microorganisms belong to the genera Lactobacillus and Bifidobacterium; however, other bacteria and some yeast may also have probiotic properties. Lactobacilli are usually described as Gram-positive, non-spore-forming and non-flagelated rods or cocobacilli, aerotolerant, fastidious, acid-tolerant, and strictly fermentative. The commercial interest in functional foods containing probiotics matches with the increasing study of their role in the digestive tract (Figueroa-González I, Quijano G, Ramirez G, Cruz-Guerrero A (2011) Probiotics and Prebiotics—perspectives and challenges. J Sci Food Agric 91: 1341-1348). Some probiotics have been shown in preliminary research to possibly treat various forms of gastroenteritis (Longstreth G F, Thompson W G, Chey W D, Houghton L A, Mearin F, Spiller R C: Functional bowel disorders. Gastroenterology 2006, 130(5):1480-1491). Irritable bowel syndrome (IBS), a common functional gastrointestinal (GI) disorder, is characterized by abdominal pain or discomfort, diarrhoea, constipation, abdominal bloating and flatulence, which are associated with changes in the frequency and form of stool and may markedly lower the quality of life (King C K, Glass R, Bresee J S, Duggan C (November 2003). Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm Rep 52 (RR-16): 1-16, Vasiljevic T, Shah N P (2008) Probiotics—From Metchnikoff to bioactives. Int Dairy J 18: 714-728 and Tuohy K M, Probert H M, Smejkal C W, Gibson G R (2003) Using probiotics and prebiotics to improve gut health. Drug Discov Today 8: 692-699). Probiotic administration, prevent the invasion of tight junctions or modulation of gut microbiota composition and/or activity might bring about relief in IBD symptoms or maintain remission from clinical symptoms (Santosa S, Farnworth E, Jones P (2006) Probiotics and Their Potential Health Claims. Nutr Rev 64: 265-274). It is important to note that health benefits provided by probiotics are strain specific, and not species- or genus-specific. Therefore, no probiotic strain will provide all proposed benefits, not even strains of the same species, and not all strains of the same species will be effective against defined healthy conditions Figueroa-González I, Quijano G, Ramírez G, Cruz-Guerrero A (2011) Probiotics and Prebiotics—perspectives and challenges. J Sci Food Agric 91: 1341-1348.
It is the principle objective of the present invention to disclose a process for the therapeutic management of diarrhea predominant irritable bowel syndrome in humans comprising the oral administration of Bacillus Coagulans SBC37-01, MTCC 5856 along with standard treatment of care. The present invention fulfills stated objective and provided further related advantages of enhancing therapeutic efficacy for irritable bowel syndrome by using/incorporating Bacillus coagulans SBC37-01 in the standard therapeutic regimen in a specific manner. Bacillus coagulans SBC37-01 is a proprietary strain of Sami Labs Limited, Bangalore, India and Sabinsa Corporation, NJ, USA that has been deposited in the Microbial Type Culture Collection and Gene Bank (MTCC), a national facility established and funded jointly by the Department of Biotechnology (DBT) and the Council of Scientific and Industrial Research (CSIR), Government of India. Bacillus coagulans SBC37-01 has been assigned the strain number MTCC 5856 and exhibits 99% genetic homology with the known bacterial strains Bacillus coagulans ATCC 31284, Bacillus coagulans NBRC 3887 and Bacillus coagulans ATCC 7050.